NCT04642573

Brief Summary

Epilepsy is a chronic brain disease that is caused by various factors and characterized by recurrent, episodic and temporary central nervous system dysfunction. In the past few decades, despite the continuous development of antiepileptic drugs, there are still 20%-30% patients with epilepsy progressing to pharmacoresistant epilepsy (PRE), which leads to a significant increase in the morbidity and mortality of epilepsy. For those fraction of PRE, surgical treatment may be the only possible way to cure epilepsy. Accurate presurgical evaluation play an important role in making surgery decision and defining surgical extent and achieve better surgical outcome. Imaging, especially interictal fluorine-18-fluorodeoxyglucose-positron emission tomography (FDG-PET) is widely used in preoperative evaluation, which is of great significance in the detection of epileptogenic foci. Previous studies on FDG-PET have found that FDG-PET has a wide range of hypometabolism inpatients of PRE varying from different epileptic origins. Therefore, exploring the characteristics of glucose metabolism originating in different brain areas of resistant epilepsy can help to better interpret the results of FDG-PET and guide the preoperative localization of such patiens and better understand the potential mechanism of seizure propagation in PRE.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

November 18, 2020

Last Update Submit

November 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • hypometabolic patterns for each patient group comparing with control group

    Due to the different epileptogenic zones in each group, the hypometabolic patterns should be different

    1-3months

Interventions

non interventional

Eligibility Criteria

Age3 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

We prospectively recruited 100 consecutive patients with pharmacoresistant epilepsy at our epilepsy center since Nov 2020. All the patients should have agreed to sign an informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Central Study Contacts

Yao Ding, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 24, 2020

Study Start

November 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2024

Last Updated

November 24, 2020

Record last verified: 2020-11

Locations